Events

Field Safety Notices about ACU-LIFE Dosage Spoon & ACU-LIFE Dosage Droppe

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Health Enterprises Inc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2011(10)
  • Date
    2011-06-01
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/acu-life-dosage-spoon-acu-life-dosage-dropper&id=9d85f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    Non-compliant acu-life dosage spoons and acu-life dosage droppers have been provided to pharmacy outlets in ireland. these dosage spoons and dosage droppers are not appropriately ce marked. although they carry the ce mark, the ce mark is not accompanied by a four digit notified body number, which confirms that the measuring function aspect of the medical device has been reviewed and certified by a notified body, as required by the medical devices legislation.
  • Action
    Advice for Pharmacies  Pharmacies and retailers should examine their stock to determine if they have any ACU-LIFE dosage spoons and/or ACU-LIFE dosage droppers.  If you find that you have these products, cease sale of these products immediately and quarantine all stock and contact Atlantico Systems immediately to obtain further instruction and guidance.  Please advise the IMB should you discover any other similar brands of dosage spoons, dosage droppers or medicines feeders that:  (a) Do not carry the CE mark  (b) Carries a CE mark but the CE mark is not accompanied by a four digit Notified Body number  Advice for Consumers  Consumers should check their dosage spoons and/or dosage droppers to determine if their device is branded ACU-LIFE dosage spoons and/or ACU-LIFE dosage droppers.  If you find that you have one of these devices, discontinue use immediately and seek an alternative. Consumers with health concerns should consult with their general practitioner.

Device

ACU-LIFE Dosage Spoon & ACU-LIFE Dosage Droppe
  • Model / Serial
  • Product Description
    ACU-LIFE Dosage Spoon & ACU-LIFE Dosage Dropper
  • Manufacturer
    Health Enterprises Inc.

Manufacturer

Health Enterprises Inc.